Rod Reduction Tool and Method to Assist in the Passage of a Connecting Rod Between Pedicle Screws

ABSTRACT

Rod delivery tools, methods for delivering a connecting rod of a pedicle screw system into seating slots of at least first and second long arm screw towers of a pedicle screw system, and a rod reduction tool and related methods for urging a distal leading end of a connecting rod and an opening of a long arm screw tower into alignment with one another, where the two are initially misaligned.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part under 35 U.S.C. §120of and claiming the benefit of U.S. patent application Ser. No.14/821,538 filed Aug. 7, 2015, entitled ROD REDUCTION TOOL AND METHOD TOASSIST IN THE PASSAGE OF A CONNECTING ROD BETWEEN PEDICLE SCREWS, whichclaims the benefit under 35 U.S.C. §119(e) of U.S. Patent ApplicationSer. No. 62/034,754, filed Aug. 7, 2014 and entitled “REDUCTION TOOL TOASSIST IN THE PASSAGE OF A CONNECTING ROD BETWEEN PEDICLE SCREWS”. Thedisclosure of each of the foregoing is incorporated by reference in itsentirety. Another application, U.S. Patent Application Ser. No.62/042,226, filed Aug. 26, 2014 and entitled “ROD DELIVERY TOOL FOR USEIN PEDICLE SCREW SYSTEMS”, is also incorporated by reference in itsentirety.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

The present invention generally relates to medical devices and methodsof use, particularly to pedicle screw systems and methods for theirinstallation.

2. The Relevant Technology

Over the past several decades, spinal surgery has increasingly become animportant option available to surgeons and patients in treating issuesrelated to the spine. Because the spine generally provides support andmovement for the body, a problem with the spine (e.g., a back disorder)can disrupt even the simplest life activities. In general, thousands ofsurgical fusions of the spine are performed each year in an attempt todecrease pain and to increase function for the patient. Stabilization ofthe spine through fusion may be accomplished in a variety of ways,including, for example, the use of pedicle screws, e.g., often used toassist in the fixation of the lumbar and thoracic portions of the spine.Such pedicle screws are generally biocompatible screws that aretypically anchored into a vertebra at the pedicle, which is a projectionfrom the body of a given vertebra that connects the body of the vertebrato an arch of the vertebra. Vertebrae generally have two pedicles.

Stability is desired in order to minimize motion while healing occurs,which healing includes fusion of the bone. Pedicle screws have beenplaced using both traditional open techniques, as well as minimallyinvasive (e.g., percutaneous) techniques. The placement process itselfcan be time consuming and difficult. Complexity and difficulty, at leastfrom the perspective of the surgeon, has in some ways been exacerbatedby the increased popularity in recent years in the use of minimallyinvasive techniques for placement of the pedicle screws and associatedinstrumentation. These techniques generally involve the use of some kindof a percutaneous access device (PAD) which attaches to the pediclescrew, or may be an extension of the screw itself. The PAD allows thesurgeon to pass a rod down through the PAD and into the accepting headsof the implanted pedicle screws so that the screws can be connected toeach other, forming a composite structure capable of stabilizing thatportion of the spine. The connecting rod is generally secured to thepedicle screws by locking nuts which may be inserted through the PADsand tightened. The PADs may eventually be removed.

Many methods have been employed to facilitate delivery and passage ofthe connecting rod down through a PAD to each respective pedicle screw,although alignment of the connecting rod, so that it is secured to eachpedicle screw, has proven to often be a challenge for even the mostexperienced surgeons. Passing a connecting rod, without directvisualization, through the appropriate receiving head of each successivescrew requires precision, patience, and on occasion, a little luck. Thereasons for this are that the receiving heads attached to or part of thetop of the pedicle screws are typically only slightly larger in diameterthan the connecting rod itself. In some cases, clearance between the twois less than a millimeter. As such, even with a rod having a taperedend, proper alignment, insertion, and seating of the rod can befrustrating.

Where only two pedicle screws are to be spanned by the connecting rod,this task may be more readily feasible, as a straight line connects twopoints. Where three or more pedicle screws are to be spanned by theconnecting rod, the process becomes much more difficult, as the three ormore screws are rarely on the same line. All too often, one or more ofthe screws in such an arrangement is enough out of alignment that thesurgeon is unable to pass the rod through all of the receiving headswithout increasing exposure (i.e., additional incisions) to the surgicalsite, to provide for direct visualization. It will be apparent thatthere exists a continuing need for improved methods for delivering suchconnecting rods, and associated devices used in delivery of theconnecting rod.

BRIEF SUMMARY

In one aspect, the present invention relates to methods for delivering aconnecting rod of a pedicle screw system into seating slots of at leastfirst and second long arm screw towers of a pedicle screw system, e.g.,after pedicle screws of the pedicle screw system have been placed intopedicles of a patient's vertebrae. Such a method may include attaching aproximal end of the connecting rod to a rod delivery tool through aclamping mechanism of the rod delivery tool; providing an incisionadjacent to a first long arm screw tower, which incision provides apathway through which at least a portion of the connecting rod isdelivered to the pedicle screw system; and inserting an elongate shaftof the rod delivery tool through the first long arm screw tower. Suchinsertion may result in at least a portion of the connecting rodremaining outside of the first long arm screw tower as the connectingrod is advanced towards the pedicle screws at the distal ends of thelong arm screw towers. For example, the proximal (e.g., “heel”) end ofthe connecting rod may be progressively advanced towards a pedicle screwat a distal end of a first long arm screw tower, while the distalleading end of the connecting rod may be progressively advanced towardsa pedicle screw at the distal end of the second (i.e., “last”) long armscrew tower. The connecting rod may be in a first orientation relativeto the elongate shaft of the rod delivery tool during at least a firstportion of advancement as the connecting rod is advanced towards thepedicle screws at the distal ends of the first and second long arm screwtowers.

Once the distal leading end of the connecting rod reaches a desiredposition, the connecting rod may be pivoted from the first orientationto a second orientation so that the connecting rod passes through boththe first and second long arm screw towers. The method may furtherinclude advancing a locking nut associated with the second long armscrew tower distally (e.g., downward) through the second long arm screwtower, over the distal leading end of the connecting rod, to secure thedistal leading end of the connecting rod into the seating slot of thesecond long arm screw tower. The proximal end of the connecting rod maybe released from the clamping mechanism of the rod delivery tool, andthe rod delivery tool may be withdrawn from the first long arm screwtower. A locking nut associated with the first long arm screw tower maybe advanced distally through the first long arm screw tower, over theproximal end of the connecting rod to secure the proximal end of theconnecting rod into the seating slot of the first long arm screw tower.In an embodiment, the steps described above may be performed in theorder described. In some embodiments, it may be possible to rearrangethe order of at least some of the steps.

In some embodiments, a third long arm screw tower may be present, e.g.,between the first long arm screw tower (into which the proximal heel endof the connecting rod is eventually seated) and the second (i.e.,“last”) long arm screw tower, into which the distal leading end of theconnecting rod is eventually seated.

In another aspect, the present invention is directed to a rod deliverytool for delivering a connecting rod of a pedicle screw system intoseating slots of adjacent long arm screw towers of the pedicle screwsystem. Such a rod delivery tool may include an elongate shaft extendingbetween proximal and distal ends, the elongate shaft being configuredfor receipt into a longitudinal channel of a long arm screw tower duringuse. The tool may include a handle at a proximal end of the elongateshaft, the handle including an actuating mechanism (e.g., a trigger) forpivoting a clamping mechanism (and a connecting rod clamped therein) atthe distal end of the shaft from a first orientation (e.g., employedduring downward advancement of the connecting rod towards the pediclescrews) to a second orientation (e.g., in which the connecting rodpasses through the long arm screws).

The tool may include a clamping mechanism at the distal end of theelongate shaft for clamping over the connecting rod, where the actuatingmechanism is configured to selectively pivot the clamping mechanism fromthe first orientation to the second orientation. The tool may includeone or more alignment guides disposed along a length of the elongateshaft for reception of a driver, for adjusting the clamping mechanism(e.g., a screw thereof) to provide selective clamping and release of theconnecting rod in the clamping mechanism.

Another aspect of the present disclosure relates to a rod reduction toolfor urging a connecting rod into alignment with a long arm screw towerof a pedicle screw system, where the connecting rod is initiallymisaligned for passage through an opening in the sidewall of the longarm screw tower. Such a rod reduction tool may include an elongate shaftextending from a proximal handle portion, the elongate shaft beingconfigured (e.g., sized and shaped) for insertion into a longitudinalchannel of a long arm screw tower during use. An alignment extensionmember including a paddle at a distal end thereof may also extend fromthe proximal handle portion. The paddle may be configured (e.g., sizedand positioned) to engage and press the distal leading end of aconnecting rod so as to align the distal end of the connecting rod withthe opening in the sidewall of the long arm screw tower that theconnecting rod is to be received in during use. A tower channel may beprovided on the rod reduction tool between the elongate alignmentextension member and the elongate shaft of the rod reduction tool, sothat when the elongate shaft is inserted into the longitudinal channelof the misaligned long arm screw tower (e.g., the second long arm screwtower), a tower portion (e.g., the sidewall of the long arm screw tower)of the long arm screw tower resides within the tower channel of the rodreduction tool, so that the elongate shaft of the rod reduction tool isinside the long arm screw tower, and the alignment extension member isoutside of the long arm screw tower, with the tower portion of the longarm screw tower portion in between.

In this orientation, rotation of the proximal handle portion of the rodreduction tool by the surgeon presses the paddle against the distalleading end of the connecting rod, urging it into the opening in thesidewall of the long arm screw tower (i.e., and down into the seatingslot), as desired. Thus, another aspect of the present disclosurerelates to a method for using such a rod reduction tool to urgealignment of the distal leading end of the connecting rod with theopening in the sidewall of the long arm screw tower, where the two areinitially misaligned. Such a method may include providing such a rodreduction tool, and inserting the elongate shaft of the rod reductiontool into the misaligned long arm screw tower, so that the alignmentextension member and paddle remain outside of the long arm screw tower.The paddle may be disposed on a side of the opening of the long armscrew tower, and may be pressed against the distal leading end of theconnecting rod to urge it into the opening of the long arm screw tower.Such urging by the paddle may be achieved by rotating the proximalhandle portion of the rod reduction tool to rotate the paddle towardsthe opening, pressing against the connecting rod, urging the distalleading end of the connecting rod into the opening of the long arm screwtower. In an embodiment, the rod reduction tool may be keyed relative tothe long arm screw tower into which it is inserted, so that the long armscrew tower only accepts the elongate shaft of the rod reduction tool ina specific orientation, and so that once inserted, the two rotatetogether relative to the pedicle screw disposed distal to the long armscrew tower. Thus, the rod reduction tool and long arm screw tower maybe rotated together, relative to the pedicle screw, and also relative tothe connecting rod. This allows the desired alignment and insertion tobe achieved between the distal leading end of the connecting rod and theopening in the sidewall of the long arm screw tower, permitting thedistal leading end of the connecting rod to become seated in the seatingslot of the long arm screw tower (e.g., the second “last” long arm screwtower).

While described with an elongate shaft that may be received into thelong arm screw tower, other embodiments of rod reduction tools may beinserted over a long arm screw tower (or other PAD), rather thannecessarily including an elongate shaft received therein. For example,various other mechanisms may be provided for engaging with the long armscrew tower (either internally, externally, or both), so that a paddleof the rod reduction tool may be disposed adjacent the opening intowhich the rod is to be urged, where the paddle can press against the rodor otherwise urge the rod and opening into proper alignment one withanother.

These and other advantages and features of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings, in which:

FIG. 1 is a perspective view of an exemplary rod delivery tool accordingto an embodiment of the present invention;

FIGS. 2A-2B are a perspective view, and close up perspective view,respectively, showing how a connecting rod may be clamped into the roddelivery tool of FIG. 1;

FIG. 2C is a perspective view similar to that of FIG. 2B, but showingthe rod in the first orientation;

FIG. 2D is a perspective view showing how the connecting rod may berotated within the clamping mechanism of the rod delivery tool, and dueto the curvature of the connecting rod, the leading end of theconnecting rod can assume various positions;

FIG. 3 is a perspective view of an exemplary long arm screw tower;

FIG. 4 is a perspective view showing a patient's back where a pluralityof pedicle screws have been placed into pedicles of a patient'svertebrae, and in which a plurality of long arm screw towers areattached to the pedicle screws so as to extend out from the patient'sback, where a scalpel is being used to cut an access opening for theconnecting rod next to the first long arm screw tower;

FIG. 5A shows preparation for insertion of an elongate shaft of the roddelivery tool into the first long arm screw tower;

FIG. 5B shows the elongate shaft of the rod delivery tool beingintroduced into the first long arm screw tower, with the connecting rodbeing transverse to the long arm screw tower, a leading end of theconnecting rod protruding through the sidewall of the long arm screwtower on one side, and the proximal heel end of the connecting rodprotruding through an opposite sidewall of the long arm screw tower onthe other side;

FIG. 5C shows further downward advancement of the elongate shaft of thetool into the first long arm screw tower, with further advancement ofthe connecting rod towards the pedicle screws;

FIG. 6A shows actuation of the actuating mechanism (e.g., a trigger) onthe handle of the rod delivery tool to begin to pivot the clampedconnecting rod at the distal end of the elongate shaft of the roddelivery tool from a first orientation for insertion of the connectingrod towards a second orientation to facilitate passage of the connectingrod through the middle long arm screw tower;

FIG. 6B shows further actuation of the actuating mechanism on the handleof the rod delivery tool, pivoting the clamped connecting rod to thesecond orientation, and in which the leading end of the connecting rodpasses through all of the long arm screw towers;

FIG. 7 shows advancement of a locking nut through the long arm screwtower over the distal leading end of the connecting rod to secure thedistal leading end of the connecting rod into the seating slot of thesecond long arm screw tower;

FIG. 8A shows insertion of a driver tool through one or more alignmentguides disposed along a length of the elongate shaft of the rod deliverytool to release the clamping mechanism which secures the connecting rodto the rod delivery tool;

FIG. 8B shows removal of the rod delivery tool from the first long armscrew tower, leaving the connecting rod disposed through the long armscrew towers;

FIG. 8C shows advancement of locking nuts through the other long armscrew towers, securing the connecting rod into the seating slots of eachof the long arm screw towers;

FIG. 9A shows cutting or other removal of the connecting bridge at thetops of the long arm screw towers, and removal of the proximal portionof the first long arm screw tower (e.g., with a breakaway tool);

FIG. 9B shows removal of the proximal portions of each of the long armscrew towers;

FIGS. 10A-10B show perspective views of two differently configured(e.g., right and left) rod reduction tools for use in urging alignmentof a connecting rod and a given long arm screw tower;

FIGS. 10C-10D show perspective views of two differently configured(e.g., right and left) alternative rod reduction tools for use in urgingalignment of a connecting rod and a given long arm screw tower;

FIG. 10E shows a perspective view of another rod reduction tool thatincludes a button and associated pin for locking rotation between thetool and the long arm screw tower;

FIG. 11A shows a scenario where the connecting rod is not aligned witheach of the long arm screw towers, so that the surgeon may havedifficulty introducing the connecting rod into one or more of the longarm screw towers (e.g., the last long arm screw tower);

FIG. 11B shows how the elongate shaft of the appropriate rod reductiontool may be inserted into a long arm screw tower, and a paddle of therod reduction tool may be used to push a leading end of the connectingrod into alignment so that it can be introduced into the opening in thesidewall of the long arm screw tower into which the elongate shaft ofthe rod reduction tool is inserted, and

FIG. 11C shows how the proximal heel end of the connecting rod may beloosened within the clamping mechanism of the rod delivery tool, andthen the paddle of the rod reduction tool used to push the leading endof the connecting rod, causing the rod to rotate as seen in FIG. 3,facilitating alignment and introduction of the leading end of theconnecting rod into the long arm screw tower into which the elongateshaft of the rod reduction tool is inserted.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS I. Introduction

The present invention relates to methods and tools for delivery of aconnecting rod of a pedicle screw system into seating slots of aplurality of long arm screw towers of the pedicle screw system, afterpedicle screws of the system have been placed into pedicles of apatient's vertebrae. Such a method may include attaching a proximal endof a connecting rod to a rod delivery tool through a clamping mechanismof the rod delivery tool (e.g., at a distal end of an elongate shaft ofsuch a rod delivery tool). An incision may be formed or otherwiseprovided next to a first long arm screw tower, providing a pathwaythrough which the proximal end of the connecting rod may be delivereddown to the distal end of the long arm screw tower. Such an incision ishelpful as the connecting rod may not be inserted lengthwise down thelong arm screw tower, but in a manner such that at least a portion ofthe connecting rod advances downward outside of the long arm screwtower, through the incision.

An elongate shaft of the rod delivery tool may be inserted through thefirst long arm screw tower, while at least a portion of the connectingrod remains outside of the first long arm screw tower, as the connectingrod is advanced downward, towards the distal end of the long arm screws,where the pedicle screws are anchored into the pedicle bone structure.The connecting rod may be in a first orientation relative to theelongate shaft of the tool, and/or relative to the hollow interiorlongitudinal channel of the long arm screw tower during insertion. Atsome point while advancing the connecting rod towards the pediclescrews, the connecting rod may be pivoted from the first orientation toa second orientation. For example, in the first orientation duringinitial advancement, the connecting rod may be relatively morevertically oriented, pivoting to a relatively more horizontalorientation in which it passes through both first and second long armscrew towers, linking them together through the connecting rod. Even inthe first orientation, the connecting rod may be oriented so as to betransverse to the elongate shaft and the hollow interior longitudinalchannel of the long arm screw tower, which may be received within oneanother. For example, the proximal “heel” end of the connecting rod mayprotrude through the sidewall of the long arm screw tower on one side ofthe long arm screw tower (e.g., the side on which the incision isformed), while the distal leading end of the connecting rod may protrudethrough the sidewall of the long arm screw tower on the opposite side ofthe long arm screw tower (e.g., 180° from the opening in the sidewallthrough which the proximal end protrudes).

At a desired position during advancement of the connecting rod towardsthe pedicle screws, the connecting rod may be pivoted from the firstorientation towards the second orientation, pivoting the distal leadingend of the connecting rod towards the second “last” long arm screw, soas to pass through the second long arm screw, as well as the first longarm screw. Once the distal leading end of the connecting rod is seatedwithin a seating slot of the second long arm screw tower, a locking nutmay be advanced distally through the second long arm screw tower,securing the distal leading end in place. The proximal “heel” end of theconnecting rod may be released from the clamping mechanism of the roddelivery tool, and the rod delivery tool withdrawn from the first longarm screw tower. A locking nut may then be advanced distally through thefirst long arm screw tower to secure the proximal end of the connectingrod in place.

Another aspect of the present invention is directed to a rod deliverytool that may be used in the described method, for delivering such aconnecting rod to the pedicle screws of the pedicle screw system. Such atool may include an elongate shaft configured for receipt into thehollow interior longitudinal channel of any of the long arm screws, anda handle at a proximal end of the shaft. The handle may include atrigger or other actuating mechanism for pivoting the clamping mechanismand/or a connecting rod clamped therein from the first orientation tothe second orientation. In addition to such a clamping mechanism at adistal end of the elongate shaft, the tool may further include one ormore alignment guides disposed along a length of the elongate shaft forreception of a driver for selectively clamping or releasing the clampingmechanism (e.g., a screw thereof) about the connecting rod when aproximal heel end of the rod is received therein. Such alignment guidesmay define a driver channel through which the driver may be inserted(e.g., spaced apart and parallel to the elongate shaft of the tool), toloosen or tighten the grip on the connection rod.

The connecting rod may be held in the tool in an orientation that istransverse to the elongate shaft of the tool, in both the first andsecond orientations of the connection rod. In the first orientation, thetransverse angle between the connecting rod and the elongate shaft ofthe tool (as well as between the rod and the channel of the long armscrew) may be relatively more shallow, but still transverse one relativeto the other. In the second orientation, the transverse angle betweenthe two may be greater (e.g., closer to perpendicular). The connectingrod may be held in the clamping mechanism in a manner so that theproximal heel end of the rod is not coaxial with the elongate shaft ofthe tool, but offset therefrom, in addition to the rod itself beingtransverse to the shaft and long arm screw channel. Because theconnecting rod is offset relative to the elongate shaft, when theelongate shaft is inserted into the long arm screw tower, at least theproximal heel end of the connecting rod remains outside of the long armscrew tower.

Another aspect of the present disclosure relates to a rod reduction tooland a method of use thereof, for use in urging a connecting rod intoalignment with an opening of a long arm screw tower that is initiallymisaligned relative to the distal leading end of the connecting rod.Such a rod reduction tool may include an elongate shaft extending from aproximal handle portion, the elongate handle being configured forreceipt into a longitudinal channel of the long arm screw tower duringuse. An alignment extension member (also elongate) and including apaddle at a distal end thereof may be provided, also extending from theproximal handle portion. The paddle may be configured to engage andpress the distal leading end of a connecting rod into alignment with anopening of a long arm screw tower during use. A tower channel may beprovided radially outward, between the elongate shaft and the alignmentextension member so that when the elongate shaft is inserted into thelongitudinal channel of the long arm screw (e.g., the “last” long armscrew) during use, the tower portion (e.g., the sidewall) of the longarm screw tower resides in the tower portion of the reduction tool, withthe elongate shaft inside the long arm screw tower, and the alignmentextension member and paddle outside of the long arm screw tower.Rotation of the proximal handle portion may cause the long arm screwtower (and its sidewall opening) to rotate together, pressing the paddleagainst the distal leading end of the connecting rod, urging the twointo alignment with one another so that the distal leading end of theconnecting rod is received into the opening, as desired. This allows thedistal leading end of the connecting rod to then be seated into theseating slot of the long arm screw tower.

II. Exemplary Methods and Devices

FIG. 1 shows an exemplary rod delivery tool 100 such as may be used inthe presently described methods for delivering a connecting rod to aplurality of pedicle screws during a spinal fusion procedure. Tool 100may include an elongate shaft 102 extending between proximal and distalends 104, 106, respectively. Shaft 102 is sized and shaped so as to bereceived within a longitudinal channel of a long arm screw tower, aswill be described in further detail below in conjunction with themethods shown beginning in FIG. 4. Such a long arm screw tower 128 isshown in FIG. 3. As seen in FIGS. 1-2D, tool 100 may further include ahandle 108 at proximal end 104 of shaft 102. Handle 108 is shown asincluding an actuating mechanism, such as a trigger 110 for pivoting aclamping mechanism 112 at distal end 106 of shaft 102. Although shownwith a trigger actuating mechanism 110, those of skill in the art willappreciate that the actuating mechanism is not particularly limited, andvarious other actuating mechanisms (e.g., other mechanical mechanismssuch as buttons, knobs, levers, etc., and/or electrical orelectromechanical mechanisms (e.g., touch button, touch screen, etc.))may be suitable for use.

Clamping mechanism 112 is shown as being pivotally attached to distalend 106 of shaft 102. FIGS. 2A and 2B better illustrate the variousstructures of the clamping mechanism 112. Illustrated clamping mechanismincludes a receptacle 114 into which connecting rod 116 may beselectively clamped. A clamp screw 118 may be provided for adjusting thewidth of receptacle 114, so that connecting rod 116 is selectivelyclampable and releasable within receptacle 114, upon adjustment (e.g.,advance or retraction) of screw 118. As shown, receptacle 114 mayinclude a recess 115, while the proximal end of rod 116 may include anenlarged heel 117, as shown. The heel may be received within recess 114.Because heel 117 is of the same shape around its full perimeter, heel117 may advantageously be rotated within receptacle 114 to any desiredorientation for clamping therein. Screw 118 may be in an end of clampingmechanism 112 so as to be accessible to a driver 146 (e.g., separatefrom tool 100), which can be coupled into screw 118 (e.g., a hex headscrew), to adjust a dimension (e.g., width) of receptacle 114,selectively clamping or releasing the outside diameter of the proximalend of connecting rod 116 in receptacle 114. As shown, screw 118 may notactually contact rod 116, but rather may serve to widen and/or narrowthe dimension of receptacle 114 as screw 118 is tightened or loosened.

Clamping mechanism pivots from a first orientation to a secondorientation, causing a connecting rod 116 received therein to also pivotfrom its first orientation to its second orientation. FIGS. 1-2B and 2Dillustrate the second orientation. FIGS. 2C and 5A illustrate the firstorientation. As will be described in further detail below, the firstorientation of the connecting rod 116 is helpful as the surgeoninitially advances the connecting rod from outside the patient's body,downwards into the surgical site, towards the pedicle screws. Onceinserted to a desired position, the trigger or other actuating mechanism110 is actuated, pivoting the connecting rod 116 to its secondorientation, for passage through the plurality of long arm screw towers.This sequence will be described in further detail below.

As seen in FIG. 1, the tool 100 is further shown as including one ormore alignment guides 120 disposed along a length of elongate shaft 102.For example, as illustrated, alignment guides 120 may be disposed on agiven side of shaft 102, e.g., the same side as clamping mechanism(e.g., where clamping mechanism 112 may be offset relative to thelongitudinal axis of shaft 102). Illustrated alignment guides 120include channels 122 disposed therethrough, so as to accommodate passagetherethrough of a driver 146 for adjusting screw 118 of clampingmechanism 112. Channels 122 are axially aligned with the head (e.g., hexhead) of screw 118 when clamping mechanism 112 is pivoted to its secondorientation, allowing a driver to be inserted through channels 122 intothe head of screw 118. When in the first orientation (FIG. 2C), theaccess surface to screw 118 may rotate counter-clockwise towards shaft102. A channel 122 may also be formed through handle 108 and/or trigger110, also aligned with channels 122 of alignment guides 120. Such aconfiguration allows the driver 146 for loosening (or tightening)clamping mechanism 112 about connecting rod 116 to be inserted throughthe proximal end 104 of tool 100, through handle 108, trigger lever 110,channels 122 of guides 120, and into head of screw 118 (when mechanism112 is in the second orientation). FIG. 8A illustrates insertion of sucha driver, so as to be generally parallel with shaft 102, during use inorder to loosen rod 116.

As shown in FIG. 2D, the illustrated clamping mechanism 112 isparticularly advantageous over various alternative mechanisms, as itallows up to full 360° rotation of connecting rod 116 within receptacle114. For example, there may be no keyed alignment required betweenreceptacle 114 of mechanism 112 and rod 116. Where connecting rod 116 iscurved, as may typically be the case, it will be appreciated that thedistal leading end of rod 116 may assume one of a variety of differentpositions, as the proximal heel end 116 a is rotated within receptacle114. As will be described in further detail below (e.g., particularly inconjunction with FIG. 11C), this clamped connection mechanism about therelatively smooth exterior outside diameter of proximal end ofconnecting rod 116 permits the surgeon to adjust the position andorientation of the connecting rod 116 within clamping mechanism 112,which can aid greatly when attempting to align and introduce the leadingend of rod 116 through the various long arm screw sidewalls. Anotherdistinct advantage of the illustrated configuration is that the surgeonmay select the particular alignment desired by the rod within theclamping mechanism 112, before clamping the rod 116 into the mechanism112. Such is not possible with existing systems, which include a recessor other keyed relationship between the rod and a clamping mechanism.This permits the surgeon to orient the rod in a custom selectedorientation, depending on the specific placement of the long arm screwtowers and pedicle screws, which can make it easier for the surgeon to“thread the needle” of the rod through each of the long arm screwtowers.

In a typical orientation of rod 116, the rod 116 may be clamped withinmechanism 112 so that the concavely curved “inside” surface or a curvedconnecting rod 116 is oriented towards the remainder of tool 100 (e.g.,shaft 102) when pivoted to the second orientation, as shown in FIG. 2B.When so oriented, the concavely curved surface of rod 106 may face anaxis of elongate shaft 102. Stated another way, if rod 116 weresufficiently long (e.g., extrapolating the length of the rod), itsleading end 116 b would intersect an extrapolated axis of the elongateshaft 102, when in the first orientation, as seen in FIG. 2C. In otherwords, such an orientation of the rod 116 in receptacle 114 turns theleading end of the rod back towards the proximal end 104 of tool 100. Ofcourse, as described in conjunction with FIG. 2D, the surgeon has theflexibility to choose a different rotational orientation of the rod 116within receptacle 114, to better accommodate the need to insert rod 116through the openings in the sidewalls of the long arm screws, dependingon the specific placement or orientation of a given long arm screwtower.

As shown in FIGS. 1-2D, the elongate shaft 102 may include an outersleeve 102 a and an interior shaft 102 b configured to slide axiallywithin the outer sleeve 102 a upon actuation of the actuating mechanism110. As perhaps best seen in FIGS. 2B-2D, the interior shaft 102 b maybe coupled to the clamping mechanism 112 (e.g., through an elongate bar102 c), so as to cause the clamping mechanism 112 to pivot towards thesecond orientation as the interior shaft 102 b slides axially within theouter sleeve 102 a.

FIG. 3 illustrates an exemplary long arm screw tower 128, includingopposed tower portions 134 extending upwardly from tulip head 130, witha groove or other break line 136 between the tower portion 134 (which iseventually removed) and tulip head 130 (which remains implanted in thepatient). As shown, the long arm screw towers 128 may be configured tobe open on two sides, through sidewalls 138 defining tower portions 134.At the proximal end of long arm screw tower 128, one open side may beopen through top surface 140, while a connecting bridge 142 may beprovided between tower portions 134 on the other side of long arm screwtower 128. As shown, one of openings (i.e., opening 138 a) is shown asopen at the top end of long arm screw tower 128, while the other opening(138 b) is shown as including bridge 142 at the top, across towerportions 134, connecting the two tower portions at the top thereof onone side.

The long arm screw tower 128 may be rotatable relative to its associatedpedicle screw (e.g., screw 126—see FIG. 7). Because of this, the longarm screw tower 128 may be rotated to any desired orientation relativeto pedicle screw 126 after pedicle screw 126 has been placed into thepatient's pedicle bone structure. This provides the surgeon greatflexibility in orienting the long arm screw towers as desired to be inthe best possible alignment with a connecting rod 116 during placementof the rod 116.

Because the top 140 of long arm screw tower 140 is open on one side, asclearly seen in FIG. 3, it is particularly well suited for use with therod delivery tool 100, in which the clamping mechanism 112 is notaligned with the elongate shaft 102, but offset therefrom. Alignmentguides 120 are similarly offset from shaft 102, so that while shaft 102may pass down the hollow interior longitudinal channel of the long armscrew tower 128, clamping mechanism 112 and guides 120 would run into aclosed or bridged top 140, when attempting to insert shaft 102 into longarm screw tower 128. Because of the opening 138 a reaching to top 140,accommodation of mechanism 112 and guides 120 is possible.

In a similar manner, the long arm screw tower 128 and rod reduction tool200, described in further detail below, are also specifically configuredto work together, as a result of the open top on one side of top 140(i.e., at opening 138 a). Specifically, tool 200 is shown as including aprotrusion 214, which would similarly run into a closed top 140, but isable to slide down into open top 140 at opening 138 a.

Because the connecting rod 116 is not passed through the long arm screwtower lengthwise, but at least the proximal end 116 a passes through anincision next to the first long arm screw tower 128 a, the system andmethod better accommodates the use of relatively longer rods, or rodswith greater curvature than where passage through the long arm screw isrequired. For example, according to the present methods, a rod having a10 inch radius of curvature may be employed. Such a curved rod, having alength of typically 3 to 3.5 inches, can be difficult to pass lengthwisethrough a percutaneous access device (PAD), as is done in other methods.This is particularly so if the rod is longer, and/or if the practitionerdetermines that greater curvature is needed. For example, a practitionermay often decide to increase the curvature in a portion of the rod toaccommodate the specific anatomy of a given patient. Sometimes, such analtered rod may resemble a hockey stick, having a very sharp curvaturetowards one end. It can be nearly impossible to pass such a rodlengthwise through a PAD.

The present methods, tools, and systems advantageously more easilyaccommodate usage of such longer rods, or rods with relatively morecurvature (e.g., having a radius of curvature of less than 10 inches).This is so because the connecting rod is not passed entirely through thelong arm screw tower, but at least the proximal end is passed downwardat a location that is next to the long arm screw tower. In addition,because the long arm screw tower includes openings 138 a and 138 b thatare typically the vast majority of the length of the long arm screwtower, the opposite ends of the rod 116 are simply allowed to passthrough either end of the long arm screw tower during advancement of therod. This is a distinct advantage over the existing art.

Turning to FIG. 4, an exemplary method for delivery of connecting rod116 that may employ tool 100 is illustrated. Prior to placement ofconnecting rod 116 of the pedicle screw system, a plurality of pediclescrews may have already been placed into pedicles of a patient'svertebrae. Placement of the pedicle screws may proceed according to anydesired technique. Exemplary pedicle screws, “tulip” heads for suchpedicle screws, depth measurement devices for aiding in selecting andplacing an appropriate pedicle screw, and exemplary techniques for theiruse are described in the inventor's earlier U.S. Pat. Nos. 8,740,956;9,084,633; 8,845,693; 8,986,318; and Published U.S. Applications2015/0173844 and 2014/0148853. Each of the above patents andapplications is herein incorporated by reference in its entirety. Whileuse of such screws, other devices, and methods as described within theinventor's earlier work may be preferred, the present methods, devices,and systems are not limited to such, and any suitable devices, screws,and methods may be employed.

The pedicle screw system 124 may include pedicle screws 126, connectingrod 116, and a plurality of long arm screw towers 128 (e.g., see FIG.7). The long arm screw towers 128 may include locking chucks and tulipheads 130, as described in U.S. Pat. No. 8,845,693, already incorporatedby reference. Such locking chucks and/or tulip heads 130 may defineseating slots 132 into which the connecting rod 116 may eventually beseated. A pedicle screw system 124 may include two or more pediclescrews 126, an equal number of long arm screw towers 128, and aconnecting rod 116. The Figures show a system including three pediclescrews 126 (FIG. 7) and three long arm screw towers 128, although itwill be appreciated that only two of each may be present, or more thanthree (e.g., four), or even more, may be present. Because only two maybe present, the first long arm screw tower is referred to herein asfirst long arm screw tower 128 a, and the “last” long arm screw tower isreferred to herein as second long arm screw tower 128 b. The middle orintermediate tower (which is optional) is referred to herein as a thirdlong arm screw tower 128 c. As described above, where long arm screwtowers are rotatable relative to their underlying pedicle screws, thisallows the surgeon to rotate the long arm screw towers 128 of FIG. 4 toany desired orientation. For example, they are shown with openings 138 aall aligned to one side.

As shown in FIG. 4, before beginning to introduce connecting rod 116into the surgical site and advancing it towards the pedicle screws, anincision 150 may be formed or otherwise provided adjacent to first longarm screw tower 128 a. As the connecting rod 116 is not passedlengthwise down long arm screw tower 128 a, but with at least a portionof rod 116 adjacent to, and outside tower 128 a, incision 150 is helpfulto accommodate the structures to be advanced therein. In other words,incision 150 provides a pathway for at least proximal end 116 a of rod116. As will be appreciated, the clamping mechanism 112 of tool 100 mayalso pass through the pathway of incision 150 during advancement of theconnecting rod 116 towards the pedicle screws 126. By way of example,incision 150 may be formed after, or at the same time as one or moreincisions through which the pedicle screws and long arm screw towersconnected thereto are placed. FIG. 4 shows a single long incision 152through which all of the long arm screw towers 128 and pedicle screwshave been placed, although it will be appreciated that in anotherembodiment, a separate, shorter incision may be provided for eachpedicle screw and associated long arm screw tower, with intact skindisposed between such adjacent relatively short incisions.

The additional incision 150 may be of any needed length so as toaccommodate clamping mechanism 112 and rod 116. Rod 116 may be orientedgenerally vertically during initial advancement through incision 150,reducing the needed width. Of course, due to the curvature of the rod116, it is not actually completely vertical. In addition, the actuatingmechanism 110 and clamping mechanism 112 may be configured so that whenthe elongate shaft 102 of tool 100 is in fact vertical, the proximalheel end 116 a of rod 116 may be offset therefrom and transverse thereto(e.g., at an angle of at least 3° relative to the shaft 102), even whenin this substantially vertical first orientation of rod 116, seen inFIG. 2C. Incision 150 may typically have a length of from about 1 to 3cm so as to accommodate the passage of clamping mechanism 112 and rod116.

As shown in FIGS. 5A-5C, once the incision 150 has been formed, theelongate shaft 102 of tool 100 may be prepared for insertion into firstlong arm screw tower 128 a. As seen, connecting rod 116 may be clampedinto clamping mechanism 112, with rod 116 in its first orientation, oreven partially pivoted towards the second orientation according to thepreference of the surgeon. Partial pivoting of rod 116 (by pressingtrigger 110 or otherwise actuating the actuating mechanism) may bedesired to swing the leading end 116 b of rod 116 towards the opening138 a, which does not include any bridge across top surface 140,allowing elongate shaft 102 to be inserted into first long arm screwtower 128 a, with clamping mechanism 112 passing through the unbridgedopening at the top 140 of opening 138 a. As will be apparent, because ofbridge 142, this results in a “keyed” relationship, so that shaft 102may only be inserted into long arm screw 128 in this one orientation,with clamping mechanism 112 (and rod 116) aligned over and withunbridged opening 138 a. Unbridged opening 138 a is open at the top,while opposite opening 138 b is closed at the top, including a bridge142, and may thus be termed a “slot”, differing from open topped opening138 a. FIGS. 5B and 5C illustrate how mechanism 112 may slide downwardsthrough opening 138 a.

As shown in FIGS. 5B and 5C, once insertion begins, the connecting rod116, in the first orientation, may be advanced downward towards thepedicle screws 126 at the distal ends of the long arm screw towers 128.As seen, during such advancement, at least a portion of rod 116 mayremain outside of first long arm screw tower 128 a. For example, theFigures show the proximal heel end 116 a protruding outwardly, throughopening 138 a, while the distal leading end 116 b protrudes outwardlythrough opening 138 b in sidewall 138 defined by tower portions 134.While shown with a central portion of rod 116 inside the first long armscrew tower, it will be appreciated that the first orientation of therod and clamping mechanism may allow the entire connecting rod 116 to becompletely outside of the first long arm screw tower 128 a, so that itis advanced down through incision 150, next to first long arm screwtower, adjacent opening 138 a. Depending on the angulation provided bythe clamping mechanism in the first orientation, just the distal leadingend 116 b of rod 116 may be in opening 138 a, or within the hollowinterior longitudinal channel of first long arm screw tower 128 a,according to the preference of the surgeon. The illustratedconfiguration, with opposite ends of the rod 116 protruding out oppositeends of the openings 138 a and 138 b may be preferred.

FIG. 5C shows downward advancement having progressed so that distalleading end 116 b of rod 116 has reached a level of tulip heads 130(e.g., rod end 116 b is shown adjacent tulip head 130 of third, “middle”long arm screw 128 c). At a desired progression of insertion (e.g., suchas this) the surgeon may actuate the actuating mechanism 110, causingthe connecting rod 116 to pivot towards the second orientation, so as topass the rod 116 through the adjacent long arm screw 128 (e.g., third,middle long arm screw 128 c). Although three pedicle screws and threelong arm screw towers are shown, it will be appreciated that any numberof such may be provided. Typically, the number of such structuresemployed in a spinal fixation surgery is two to four.

FIG. 6A shows the connecting rod 116 being pivoted towards its secondorientation, now passing through the adjacent long arm screw tower 128c. As shown in FIG. 6B, the rod 116 may continue to be pivoted towardsthe second orientation, so as to pass through the final long arm screwtower 128 b. Depending on the preference of the surgeon, during suchpivoting of rod 116, elongate shaft 102 may continue to be furtheradvanced downward into first long arm screw tower 128 a, as the distalleading end 116 b of rod 116 swings towards the second (e.g., final)long arm screw tower 128 b.

Once the connecting rod 116 spans all of the long arm screw towers(e.g., with rod 116 in or near the seating slots in the tulip heads 130of each tower 128), the distal leading end 116 b of rod 116 may besecured in the seating slot 132 defined by tulip head 130 of the longarm screw tower 128 b. This may be accomplished by advancing a lockingnut 144 associated with second long arm screw tower 128 b distally,downward through tower 128 b (e.g., using a locking nut driver 146), asseen in FIG. 7. The distal end of tower portion 134 and the proximalportion of tulip head 130 may include internal threading to accommodatescrewing locking nut 144 over distal leading end 116 b, securing it intoplace. At this stage, the proximal end 116 a of rod 116 may still beclamped within clamping mechanism 112, and may or may not be fullyseated against the bottom of the seating slot 132 of first long armscrew tower 128 a.

As seen in FIG. 8A, in any case, once leading end 116 b is secured withlocking nut 144, a driver 148 may be inserted through channels 122 ofalignment guides 120, into the head of clamping screw 118. Rotation ofdriver 148 may loosen clamping mechanism 112, loosening the grip on rod116, allowing release therefrom. Once rod 116 is loosened from clampingmechanism 112, the rod delivery tool 100 may be withdrawn, as shown inFIG. 8B. As shown in FIG. 8C, with tool 100 out of the way, a lockingnut 144 may be advanced through first long arm screw tower 128 a,securing the proximal end 116 a of rod 116 in place. A locking nut 144may also be advanced and secured over a central portion of rod 116,through the middle long arm screw tower 128 c, where such a third (orfourth) long arm screw and pedicle screw are present.

Each of the locking nuts 144 may be further tightened to a desiredforce, e.g., 10 Nm. Any suitable tool such as a torque wrench (notshown), may be used for such purpose. The final tightened force appliedto locking nuts 144 may be selected to ensure that the locking nuts androd 116 remain in their desired positions within the installed pediclescrew system 124. Once the locking nuts 144 have been installed, thetower portions 134 of each of the long arm screw towers 128 may beremoved. This may be achieved by cutting or otherwise removing the smallconnecting bridge 142 between tower portions 134, followed by insertinga suitable tab break away tool (not shown) over one of the towerportions, and bending it laterally outward, so that the tower portionsnaps off at break line 136. FIG. 9A shows one tower portion 134 havingbeen removed from the first long arm screw tower 128 a, with theremaining tower portion 134 still to be removed. In FIG. 9B, all of thetower portions 134 have been removed from long arm screw towers 128,leaving just the tulip heads 130 of each of the long arm screw towers128 in place.

FIGS. 11A-11C illustrate use of a rod reduction tool 200 which may behelpful in urging the distal leading end 116 b of connecting rod 106into the openings between the towers 134 of any given long arm screw128. FIGS. 10A and 10B show perspective views of exemplary rod reductiontools 200 and 200′. For example, particularly where three or more longarm screws and associated pedicle screws are employed in the spinalfusion, it may be difficult to achieve insertion of the leading end 116b of rod 116 through the final long arm screw tower 128 b in thesequence of long arm screw towers 128. FIG. 11A illustrates such ascenario, where the connecting rod 116 has successfully passed throughlong arm screws 128 a and 128 c, but the leading end 116 b is notaligned with opening 138 a of long arm screw tower 128 b.

FIGS. 10A-10B illustrate the exemplary rod reduction tools 200, 200′,which are similar to one another. Tool 200 may be referenced, althoughit will be appreciated that tool 200′ includes similar features. Rodreduction tool 200 includes an elongate shaft 202 extending from aproximal handle portion 204. Proximal handle portion may be enlarged,configured for being gripped by the surgeon during use, so that thesurgeon may easily rotate tool 200. FIGS. 10A-10B show handle portion204 including longitudinal recesses formed therein, for improved gripand torque in the surgeon's hand. Elongate shaft 202 may be aligned witha longitudinal axis of tool 200, so as to be centrally disposed, andextend distally from handle portion 204. Shaft 202 may be configured forinsertion and receipt into the top of long arm screw tower 128 duringuse, similar to shaft 102 of rod delivery tool 100. While shown with ashaft 202 for receipt into a long arm screw tower, it will beappreciated that other engagement between the tool 200 and the long armscrew may be provided (e.g., a sleeve that fits over the top of the longarm screw tower, engaging externally and/or internally therewith, etc.).Such a sleeve may include an inwardly oriented projection (e.g.,analogous to projection 214), that could engage within one of thesidewall openings of the long arm screw tower 128 (e.g., opening 138 a).Such various alternative structures will be apparent to one of skill inthe art in light of the present disclosure. One such example is shown inFIGS. 10C-10D, showing rod reduction tool 200 a (analogous to tool 200)and rod reduction tool 200 a′ analogous to tool 200′, but including anelongate shaft that is a sleeve 202 a which fits over the screw tower,instead or in addition to a shaft that fits within the screw tower asshown with shaft 202 in FIGS. 10A-10B. This sleeve is generally anextension of the sleeve member 204 immediately below the handle shown inFIGS. 10A and 10B.

As will be apparent, the various structures of tools 200 a and 200 a′may be generally similar or identical to tools 200 and 200′. Whereprojection (protrusion) 214 is shown formed on the exterior surface ofinner shaft 202, projection 214 a may be formed on an interior surfaceof sleeve 202 a. While the tools of FIGS. 10A-10B are described whereexternal projection or protrusion 214 causes that portion of the solidshaft 202 to have a radius greater than the radius of the longitudinalchannel of long arm screw tower 128, so that protrusion 214 cannot bereceived into the channel, it will be apparent that with the tool ofFIGS. 10C-10D, projection 214 a causes sleeve 202 a at the point of thekeyed protrusion 214 a, to have a radius at the inside edge of theprotrusion, that is less than the outside radius of the longitudinalchannel of the long arm screw tower. This makes is so that when thesleeve 202 a is placed over the long arm screw tower, the keyedprotrusion 214 a engages in an opening between sidewall portions of thelong arm screw tower 128, so that the long arm screw tower rotates withthe sleeve. Because of the keyed arrangement, fitting of the sleeve overthe long arm screw tower is only possible when the keyed protrusion 214a is properly aligned with the open topped opening 138 a.

Alignment extension member 206 a and 206 a′ may extend (e.g., directly)from sleeve 202 a (e.g., from a distal end thereof). Tools 200 a and 200a′ can be used analogously as described below and shown for tools 200and 200′ in FIGS. 11A-11C, except that engagement of sleeve 202 a wouldbe over the long arm screw tower 128 rather than within long arm screwtower (as shaft 202 of FIGS. 10A-10B is). In embodiments where thesleeve is employed that fits over the screw tower, as in FIGS. 10C and10D, it may be desirable for the sleeve 202 a to be longer than theanalogous sleeve member shown in FIGS. 10A and 10B immediately below thehandle 204 to provide greater operational stability during use.Moreover, the alignment extension member in the embodiment shown inFIGS. 10C and 10D may extend from the sleeve as shown in FIGS. 10C and10D. In some instances, the internal shaft 202 as shown in FIGS. 10A and10B can be eliminated from the reduction tool and the sleeve 202 a(e.g., see FIGS. 10C and 10D). In another embodiment 200 b, the sleeve202 a may be locked to the tower with a depress-able button and pinmechanism 214 b (FIG. 10E), so that those members rotate together. Forexample, such a pin 214 b may be receivable through a hole (or holes)215 b. Although holes are shown on both sides, it is not necessary thatholes be formed on both sides of sleeve 202 a for pin 214 b to engagethe long arm screw tower, to lock the long arm screw tower 128 intorotation with tool 200 b. Although tool 200 b is shown as analogous totool 200 a and 200 of FIGS. 10A and 10C, it will be appreciated that asecond tool may also be provided, analogous to tool 200′ and 200 a′ ofFIGS. 10B and 10D. It is conceivable that both the extended sleeve(e.g., 202 a) that engages the outside of the long arm screw tower, anda shaft that fits within the tower (e.g., 202) could be provided in thesame rod reduction tool.

Tool 200 is shown as also including an alignment extension member 206including a paddle 208 at a distal end of member 206. Alignmentextension member 206 (206′) is also elongate, extending from proximalhandle portion, but may be offset relative to a longitudinal axis oftool 200, as shown. Paddle 208 is shown as including a flat planar face210 to press against the distal leading end 116 b of a connecting rod116, so as to urge the connecting rod 116 and the opening 138 a of thelong arm screw tower 128 into alignment with one another, but any shapeor size is suitable that engages the connecting rod and urges into thedesired condition. The paddle is typically an enlarged part of thealignment extension member.

A tower channel 212 is shown as being provided between elongate shaft202 and alignment extension member 206 when the elongate shaft fitsinside the longitudinal tower of the screw, so that a space existsbetween shaft 202 and member 206, into which one of tower portions 134may be inserted during use of tool 200. Member 206 and paddle 208 areshown as being longer than shaft 202. For example, the length of member206 and paddle 208 together may be approximately equal to that of thelong arm screw tower that it is used with, so that when mated together,the paddle 208 reaches near or to the distal bottom end of the long armscrew tower 128 b (e.g., to the bottom of unbridged opening 138 a). Asseen in FIGS. 11B-11C, when tool 200 is inserted into second long armscrew tower 128 b, the elongate shaft 202 of (FIGS. 10A and 10B) resideswithin the longitudinal channel of the long arm screw tower 128 b, whilealignment extension member 206 remains outside of the long arm screwtower 128 b, with member 206 disposed against one of tower portions 134,tower portion 134 being in tower channel 212.

Elongate shaft 202 may further include a keyed protrusion 214, so thatwhen elongate shaft 202 is inserted into the long arm screw tower, thekeyed protrusion engages between tower portions 134 (in unbridgedopening 138 a). As a result of this keyed relationship, the generallyoval shaped protrusion 214 engages with the ends of tower portions 134defining opening 138 a, preventing rotation of tool 200 relative to orwithin long arm screw 128. As a result, both structures rotate together.In other words, when the surgeon rotates proximal handle portion 204 oftool 200 with shaft 202 engaged in long arm screw 128, the long armscrew 128 will rotate with tool 200. As seen in FIGS. 11B-11C, the keyedprotrusion 214 may be larger than the longitudinal channel of the longarm screw tower, so that protrusion 214 is not actually received intolong arm screw tower 128, but slides along opening 138 a, which isunbridged at its top, so as to accommodate sliding receipt of protrusion214 therein. In this way, elongate shaft 202 is only receivable into thelong arm screw tower 128 in this particular orientation, with opening138 a (unbridged at top) axially aligned with protrusion 214, so thattool 200 can slide into long arm screw tower 128 in this orientation,but not the opposite orientation (i.e., protrusion 214 hits bridge 142),or any other orientation (i.e., protrusion 214 hits tower portions 134).In other words, protrusion 214 and the adjacent portion of shaft 202 hasa radius greater than the radius of the longitudinal channel of long armscrew tower 128, so that protrusion 214 cannot be received into thechannel, only into the open topped opening 138 a. When the protrusion ismounted on the sleeve such as sleeve 202 a of FIGS. 10C and 10D, theprotrusion extends inward from the wall of the sleeve and thus is keyedto slide within the opening in the sidewall of the long arm screw tower128 when the sleeve 202 a is place over the tower 128.

As seen, the keyed protrusion 214 may be oval shaped, although variousother shapes are of course possible, to serve as a key for receipt intoopening 138 a. As shown, the alignment extension member 206 and paddle208 may be on the same side, with paddle 208 (particularly paddle edge208 a) being generally aligned with an edge 216 a of oval keyedprotrusion 214. Thus, keyed protrusion 214 is received into opening 138a, while paddle 208 resides just to the side of opening 138 a, where itcan press against the distal leading end of the connecting rod 116,which is initially misaligned, pressing the opening 138 a and connectingrod 116 into alignment with one another. When shaft 202 a is a sleeveand an extension of the sleeve immediately below the handle as in FIGS.10C and 10D, the protrusion extends inward from the inside of sleeve 202a. Still other mechanisms may be employed to engage the sleeve to thescrew tower wall to prevent rotation of tool 200 relative to or withinlong arm screw 128. For example, as seen in FIG. 10E, a pin connected toa depress-able button 214 b placed on the outside of the sleeve 202 amay be employed which operates to press a pin from or through the sleeve202 a and into the opening 138 a, 138 b between the sidewalls 138 of thetower 128 when the button 214 b is depressed, through hole 215 b insleeve 202 a, thus engaging the sleeve 202 a with the long arm screwtower 128 and making those structures rotate together. One suchmechanism is shown in FIG. 10E where the sleeve 202 a is longer thansleeve member extending from the handle 204 shown in FIGS. 10A and 10Bto provide stability in operation where the interior shaft 202 may notbe present. Such a button-pin mechanism is especially suitable where theopening at the top of the tower is bridged over its entirecircumference, as such a bridge would inhibit the protrusion 214, 214 ain FIGS. 10A-10D from sliding through the opening at the top of thetower (i.e., open top of slot 138 a). Instead, the button of thebutton-pin mechanism in FIG. 10E is depressed or inserted after thesleeve 202 a is placed over the tower 128 and the pin 214 b movesthrough the opening (e.g., 138 a and/or 138 b) and into the long armscrew tower, thus engaging or “locking” the sleeve 202 a to the tower128. Other mechanisms will be apparent to those with skill in the art toengage or lock the tool to the long arm screw tower to prevent theelongate shaft (e.g., including a sleeve 202 a) from rotating withrespect to the long arm screw.

As shown, the alignment extension member 206 and 206 a may include aninternal surface 218 that is concavely curved so that the tower channel212 is shaped to accommodate a convexly curved tower portion 134 of longarm screw 128.

FIG. 10A shows a left hand embodiment in which the alignment extensionmember 206 and paddle 208 are on the left side of the elongate shaft 202to tool 200, to urge connecting rod 116 in a counter-clockwise directionrelative to opening 138 a in the sidewall 138 of long arm screw tower128 b during use. Depending on the particular misalignment of the distalleading end of the connecting rod 116, such a configuration may beuseful for correcting the misalignment, and urging receipt of the distalleading end of the connecting rod 116 into the desired opening 138 a. Ifthe connecting rod is misaligned in the other direction, i.e., whereclockwise rotation is desired, a right hand embodiment of a tool 200′that is otherwise similar to tool 200, but in which the alignmentextension member 206′ and paddle 208′ (particularly paddle edge 208 a)are positioned on the opposite side, aligned with the other edge 216 bof keyed protrusion 214 may be used.

FIG. 11A shows a scenario where the distal leading end 116 b of rod 116is misaligned relative to opening 138 a of second long arm screw tower128 b. FIG. 11B shows insertion of elongate shaft 202 of rod reductiontool 200 into the top 140 of second long arm tower screw 128 b, withpaddle 208 being used to push or otherwise urge distal leading end 116 bof rod into the bottom of opening 138 a. On occasion, even with suchurging of paddle 208, it can be difficult to cause the desired alignmentbetween distal leading end 116 b and opening 138 a of the second longarm screw 128 b. As shown in FIG. 11C, the surgeon may choose to loosenthe proximal heel end 116 a of the rod 116, which will advantageouslyallow the rod 116 to rotate thereabout, as shown in FIG. 2D. With theproximal heel end 116 a of rod 116 loosened, contact of paddle 208against distal leading end 116 b will typically easily facilitate thedesired alignment. This may be particularly helpful in embodiments wherethe rod reduction tool locks with and rotates with the long arm screwtower, as rotation of paddle 208 may also actually rotate opening 138 a.Because the rod 116 is loosened, it can rotate as shown in FIGS. 11C and2D, causing the rod to align with opening 138 a. Such an advantage ofthe ability to rotate the rod 116 about the proximal end providesvaluable millimeters of lateral movement of the distal leading end,making it much easier for the practitioner to achieve the desiredalignment. Such advantage is provided through the clamping mechanism 112as described herein, which advantageously allows up to 360° rotation.Many existing rod delivery methods and systems simply do not providesuch flexibility in orienting the rod, as needed for insertion into thevarious long arm screw towers.

Numbers, percentages, or other values stated herein are intended toinclude that value, and also other values that are about orapproximately the stated value, as would be appreciated by one ofordinary skill in the art encompassed by embodiments of the presentdisclosure. A stated value should therefore be interpreted broadlyenough to encompass values that are at least close enough to the statedvalue to perform a desired function or achieve a desired result. Thestated values include at least the variation to be expected in asuitable manufacturing process, and may include values that are within25%, within 20%, within 10%, within 5%, within 1%, etc. of a statedvalue. Furthermore, the terms “substantially”, “similarly”, “about” or“approximately” as used herein represents an amount or state close tothe stated amount or state that still performs a desired function orachieves a desired result. For example, the term “substantially” “about”or “approximately” may refer to an amount that is within 25%, within20%, within 10% of, within 5% of, or within 1% of, a stated amount orvalue.

Ranges between any values disclosed herein are contemplated and withinthe scope of the present disclosure (e.g., a range defined between anytwo values (including end points of a disclosed range) given asexemplary for any given parameter).

As used in this specification and the appended claims, the singularforms “a,” “an” and “the” include plural referents unless the contextclearly dictates otherwise.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

What is claimed is:
 1. A rod reduction tool for urging alignment of aconnecting rod with a long arm screw tower of a pedicle screw where theconnecting rod is misaligned for passage through an opening in asidewall of the long arm screw tower, the rod reduction tool comprising:a proximal handle portion; an elongate shaft extending from said handleportion, said shaft being configured to fit at least one of over or intothe long arm screw tower, an alignment extension member extending fromat least one of said handle portion or from said shaft, said alignmentextension member including a paddle at a distal end thereof, said paddlehaving a surface that enables engagement with a connecting rod to alignthe connecting rod with the opening in the sidewall of the long armscrew tower.
 2. A rod reduction tool as in claim 1, wherein the elongateshaft is configured for receipt into a hollow channel of a long armscrew tower.
 3. A rod reduction tool as in claim 2, wherein a sidewalldefining a longitudinal channel of the long arm screw tower ispositioned between the alignment extension member and the elongate shaftduring use so that when the elongate shaft is inserted into thelongitudinal channel of the long arm screw tower during use, at least aportion of the elongate shaft resides within the longitudinal channel,and the alignment extension member resides outside of the long arm screwtower.
 4. A rod reduction tool as in claim 2, wherein the elongate shaftincludes a keyed protrusion disposed thereon so that when the elongateshaft is inserted into the long arm screw tower during use, the keyedprotrusion engages in an opening between sidewall portions of the longarm screw tower, so that the long arm screw tower rotates with the rodreduction tool.
 5. A rod reduction tool as in claim 2, wherein thealignment extension member and the paddle are disposed on a right sideof the opening in the long arm screw tower.
 6. A rod reduction tool asin claim 2, wherein the alignment extension member and the paddle aredisposed on a left side of the opening of the long arm screw tower.
 7. Acombination comprising: a rod reduction tool as in claim 2; and a longarm screw tower.
 8. A combination as in claim 7, wherein the toolcomprises means to prevent the elongate shaft from rotating with respectto the long arm screw tower.
 9. A combination as in claim 8, wherein themeans comprises a keyed protrusion disposed on the elongate shaft, saidelongate shaft having at the point of the keyed protrusion a radius thatis greater than the radius of a longitudinal channel of the long armscrew tower, so that when the elongate shaft is placed in the long armscrew tower, the keyed protrusion engages in an opening between sidewallportions of the long arm screw tower, so that the long arm screw towerrotates with the elongate shaft.
 10. A combination as in claim 8,wherein the means comprises a depress-able button and the elongate shaftcomprises a sleeve that fits over the long arm screw tower, saiddepress-able button being on the sleeve and connected to a pin,whereupon depressing said button, the pin passes from said sleeve intothe opening between sidewall portions of the long arm screw tower.
 11. Arod reduction tool as in claim 1 wherein the elongate shaft is in theform of a sleeve that fits over the long arm screw tower and thealignment extension member extends from said sleeve, said alignmentextension member including the paddle, the paddle being configured toengage and press the distal end of the connecting rod so as to align thedistal leading end of the connecting rod with the opening in a sidewallof the long arm screw tower.
 12. A rod reduction tool of claim 11,wherein the elongate shaft comprises means that prevent the long armscrew tower from rotating with respect to the elongate shaft when theelongate shaft is fitted at least one of over or into the long arm screwtower.
 13. A rod reduction tool as in claim 12, wherein the meanscomprises a keyed protrusion disposed within said sleeve, said sleevehaving, at the inside edge of said protrusion, a radius that is lessthan the outside radius of the long arm screw tower, so that when thesleeve is placed over the long arm screw tower the keyed protrusionengages between an opening in sidewall portions of the long arm screwtower, the protrusion being keyed for insertion into and sliding withinthe opening.
 14. A rod reduction tool as in claim 12, wherein the meanscomprises a depress-able button on said sleeve, said button beingconnected to a pin, where upon depressing said button, the pin passesfrom said sleeve into the opening between sidewall portions of the longarm screw tower.
 15. A rod reduction tool as in claim 11, wherein thealignment extension member and the paddle are disposed on a right sideof the opening in the long arm screw tower.
 16. A rod reduction tool asin claim 11, wherein the alignment extension member and the paddle aredisposed on a left side of the opening in the long arm screw tower. 17.A combination comprising: a rod reduction tool as in claim 11; and along arm screw tower.
 18. A combination as in claim 16, wherein the toolcomprises means to prevent the elongate shaft from rotating with respectto the long arm screw tower.
 19. A combination as in claim 18, whereinthe means comprises a keyed protrusion disposed within the sleeve, theelongate shaft having, at the inside edge of the keyed protrusion, aradius that is less than the outside radius of the long arm screw tower,so that when the sleeve is placed over the long arm screw tower thekeyed protrusion engages in an opening between sidewall portions of thelong arm screw tower, so that the long arm screw tower rotates with thesleeve.
 20. A combination as in claim 18 wherein the means comprises adepress-able button being connected to a pin on the sleeve whereupondepressing said button, said pin slides from the sleeve into the openingbetween the sidewall portions of the long arm screw tower.